Trial SNCTP000003718
Publication Kharat A, ERJ Open Res, 2021 (published paper)
Dates: 2020-04-06 to 2020-04-25
Funding: No specific funding (None)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Switzerland Follow-up duration (days): 28 | |
| Inclusion criteria | Patients aged ≥18 years ; admitted to a medical ward for treatment of COVID-19 pneumonia ; low-flow oxygen therapy (defined as 1–6 L·min−1) through nasal cannulas to obtain a SpO2 level of 90–92%. |
| Exclusion criteria | Patients initially treated in the ICU or high-dependency unit and recovering from ARDS; those with oxygen needs >6 L·min−1 using a nasal cannula or with >40% inspiratory oxygen fraction (FiO2) using a Venturi mask to obtain a SpO2 level of 90–92%; pregnant women; terminally ill patients; and those unable to self-prone. |
| Interventions | |
| Treatment
Prone Position Prone position promoted for 12 h per day with change of position every 4 hours, for 24 h |
|
| Control
Standard care ( / ) Definition of Standard care: Usual care consisted of 1) oxygen titration with nasal cannula according to our institutional recommendations to target SpO2 values between 90% and 94%. Nurses carried out at least six routine rounds per 24 h to monitor oxygen needs and adapt oxygen flow to the prescribed SpO2 target; 2) empirical antibiotics for community-acquired pneumonia; 3) an association of hydroxychloroquine and lopinavir/ritonavir as proposed by our institutional guidelines; and 4) a restrictive fluid strategy. | |
| Participants | |
| Randomized 27 participants (n1=10 / n2= 17) | |
| Characteristics of participants N=27 Mean age : 57.8 17 males Severity : Mild: n=0 / Moderate: n=26/ Severe: n=1 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report CAF outcome data timepoints | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
High |
| General comment |
In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias (SNCTP000003718, date of registration unclear). Neither protocol nor statistical analysis plan was available. There was a small difference between the inclusion criteria in the registry (oxygen dependence ≥1 to <5 L/min) and the article (oxygen dependence 1 to 6 L/min). There was no difference in the intervention. Outcomes were not reported in the registry. No review-specific outcomes were reported. Although designed as a cluster-randomized trial, following the closure of some randomized COVID wards due to a drop-off in admitted patients, four patients were randomized individually. The trial was terminated before reaching its planned sample size due to a lack of eligible admitted patients.
This trial was updated on July 28th, 2021 with data gained from contact with authors. |